Kornimate/medical-research-clean huggingface dataset:
negative pressure wound therapy for the prevention of surgical site infection following lower limb revascularization

Conditions: Surgical Wound Infection; Peripheral Vascular Diseases

Summary: the purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (ssis) in patients undergoing surgery to restore blood flow to the lower limb(s). negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. the device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector. the investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.

the study is a non-blinded randomized control trial. the study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (bmi \> 30, previous femoral cut-down). the investigators expected to find a lower surgical site infection rate in patients using the npwt device. patients after giving informed consent will be randomized to receive either npwt or standard wound therapy following tier lower-limb revascularization operative. both will be applied under sterile conditions immediately post-operatively. the intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two. the data will be analyzed with an intention to treat analysis.

Eligibility criteria:
inclusion criteria: * bmi \> 35 * previous femoral exposure * undergoing lower-limb revascularization exclusion criteria: * cannot obtain seal * non-primary wound closure * pre-existing infection * endovascular repair

Keywords: surgical site infection vascular surgery negative pressure wound therapy
the use of reminders in implementing an e-learning program in general practice

Conditions: Dementia

Summary: to evaluate general practitioners use and reuptake of an e-learning programme in diagnostic evaluation of dementia after an intervention consisting of three mailed reminder letters. there is no direct patient involvement in this study.

the three mailed reminder letters will be mailed to the general practitioners (gps) in january 2007. the periods where the e-learning programme will identify gps using the programme are: period before: november 1. and 6 weeks forward. period after: medio marts and 6 weeks forward. all log files are kept anonymous for the principal study investigator by the danish medical association.

Eligibility criteria:
inclusion criteria: * general practitioners working in copenhagen municipality october 1st 2006 exclusion criteria: * general practitioners stopping to work in study period

Keywords: heading health plan implementation computer-assisted instruction general practice dementia education
a study of dpk-060 to investigate clinical safety and efficacy in patients with acute external otitis

Conditions: Acute Otitis Externa

Summary: the primary objective of this study is to evaluate safety and tolerability of dpk-060 2% ear drops compared to placebo for dpk-060 ear drops in patients with acute external otitis. the secondary objectives are to evaluate clinical cure and microbiological growth following treatment with dpk-060 2% ear drops compared to placebo for dpk-060 ear drops.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of acute external otitis of a severity degree not requiring specialist care * age 12 years and older exclusion criteria: * known or suspected perforation of the tympanic membrane * a clinical diagnosis of chronic suppurative otitis media, acute otitis media, acute otorrhea or malignant otitis externa * local ear canal abnormalities * congenital abnormalities of the external auditory canal or obstructive bony exostosis * mastoiditis or suppurative non-infectious ear disorders (e.g. cholesteatoma) * malignant tumour of the external auditory canal * history of otologic surgery (except for surgery confined to the temporomandibular joint) * seborrheic dermatitis or other dermatological conditions of the external auditory canal that would complicate evaluation * current or prior use (within 7 days) of ear washes using alcohol, vinegar or other astringents * any clinically relevant past or present infectious/viral disease * current infection requiring systemic antimicrobial therapy * current or prior use of systemic (within 14 days) or topical (within 7 days) antibiotics * current or prior use of systemic (within 30 days) or topical (within 7 days) steroids * history of immune dysfunction/deficiency and immunosuppressive therapy * diabetes mellitus
comparison of postoperative recovery of sevoflurane and propofol after transsphenoidal surgery

Conditions: Pituitary Adenoma

Summary: currently, total intravenous anesthesia (tiva) and inhaled anesthesia are both commonly used for transsphenoidal pituitary adenoma resection. however, optimal choice for anesthesia maintenance in transsphenoidal surgery remains unclear. previous studies focusing on this question provided fragmentary assessment and controversial results. the goal of this clinical trial is to investigate whether propofol and sevoflurane have different effect on post-anesthetic recovery after transsphenoidal resection of pituitary adenoma.


Eligibility criteria:
inclusion criteria: 1. men or women, aged from 18 to 70 2. american society of anesthesiologists (asa) class i - iii 3. patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation exclusion criteria: 1. patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery 2. severe pulmonary disease, saturation of peripheral oxygen (spo2) \< 90% 3. severe nervous system disease with consciousness disorder 4. patients scheduled for intensive care unit (icu) after surgery 5. pregnancy

Keywords: anesthesia transsphenoidal surgery enhanced recovery after surgery
a novel parent education program for early intervention

Conditions: Preterm Infant; Full-term Infant

Summary: one in ten infants born in the usa is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age. because existing assessments do not reliably identify motor and cognitive delays early in development, many infants born preterm do not receive early intervention until they are older and their delays are more pronounced. this project aims to address the need for an effective, affordable, novel early intervention model for the first months of life for preterm infants.

one in 10 children in the united states is born preterm and at risk for disabilities that can impair movement and cognition. research suggests that targeted early intervention can effectively improve ability and function for these children. however, two key obstacles limit the provision of early intervention services in the first half-year of life. first, the existing diagnostic tools are limited in their ability to identify motor and cognitive delays at early ages. second, in the medical model there is a lack of understanding of developmental science and how experiences in the first months of life can impact the development of future abilities. in effect, there has been lack of knowledge regarding who should receive early intervention services and what activities should be the focus of those services in infancy. this project aims to address these challenges by testing the fidelity and short-term efficacy of a novel intervention providing education for parents of preterm infants. the intervention will educate parents on ways to handle, position, and play with their infants to provide infants safe opportunities to explore new ways of moving and controlling their bodies and interacting with objects. intervention provision will be documented and outcomes will be compared for 20 infants randomized to receive one of two types of developmental education. pre- and post-assessments will compare motor control in prone, reaching ability, daily positioning practices, and parent-child interactions with toys to determine if there are differences in the short-term effects of the intervention. intervention will occur for two months with parents logging activity daily. measures related to dosage and how parents perform the intervention activities will be gathered to assess fidelity of the intervention. aim 1: to measure aspects related to fidelity for families participating in the study. aim 2: to determine if there is a difference in developmental outcomes for children who receive the intervention.

Eligibility criteria:
inclusion criteria: * infant meeting the age criteria * access to the internet * residence within driving distance of the university of delaware * parental ability to read and communicate in english exclusion criteria: * genetic diagnosis * progressive diagnosis such as spinal muscular atrophy * medical or movement restrictions that would interfere with participation in the study activities

Keywords: development infant preterm parent education play full-term
web-mediated risk assessment for endoscopic screening of colorectal polyps

Conditions: Colorectal Polyp

Summary: colorectal polyps are risk factors for cancer. early detection of polyps is critical for colorectal cancer management. however, the diagnosis rate of patients with colorectal polyps is still low. therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.


Eligibility criteria:
inclusion criteria: 1. age 18-65. 2. signed informed consent exclusion criteria: 1. severe back ground disease including malignancy. 2. state after gastric surgery. 3. copd, chf, crf and any disease with respiratory disturbances. 4. deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.

Keywords: colorectal polyp screening risk assessment
dietary phosphate and serum phosphorus

Conditions: Phosphorus Metabolism Disorders

Summary: overall study design is to review national health and nutrition examination survey (nhanes) data 1999-2008 for nutrition risk according to kidney function. substudies will be performed to review the association of nutrients and overall dietary intake compared to biomarkers available in nhanes during this period.

data from nhanes 2003-2006 were used to evaluate the relationship between estimated dietary phosphorus intake and the measured serum phosphorus. the following variables were used: 1. demographics: age, sex, race/ethnicity 2. dietary variables: foods, food groups (as reported by the united states department of agriculture (usda) method, further standardized to the academy of nutrition and dietetics method for portion size and then divided into groups having inorganic phosphate additives or no inorganic phosphate additives), food weight (g), phosphorus (mg), dietary supplements 3. socioeconomic variables: education, family income 4. laboratory variables: serum creatinine, phosphorus; urine albumin, creatinine 5. clinical assessments: hypertension (proportion having blood pressure ≥140 millimeters of mercury (mmhg) diastolic or ≥90 mmhg systolic or taking antihypertensive medications); hyperglycemia (proportion having serum glucose \>126 mg/dl or taking medications for diabetes); kidney function based on chronic kidney disease epidemiology collaboration (2009) equation, evaluated in 15 milliliters/min/1.73m2 increments from \ 105; anthropometrics (bmi, kg/m2; obesity class i, ii, iii)

Eligibility criteria:
inclusion criteria: * serum creatinine exclusion criteria: * pregnancy * no dietary intake interview * dietary intake interview not valid * answered the question "have you had dialysis in the past year?" as "yes"

Keywords: kidney disease recommended dietary allowances nutrition assessment food dietary proteins vitamin d dietary fats ethnology continental population groups phosphorus, dietary phosphorus/analysis
lifestyle eating and performance (leap) program for the treatment of irritable bowel syndrome (ibs)

Conditions: IBS - Irritable Bowel Syndrome

Summary: a three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.

this study will have 60 participants with irritable bowel syndrome (ibs) for a duration of three months. the procedures will consist of anthropometric measures, blood pressure, questionnaires, and a blood sample. there will be seven visits with one including a virtual meeting with a registered dietitian involved in the lifestyle eating and performance (leap) program. with these procedures the investigators will test the effectiveness of the leap program for the treatment of irritable bowel syndrome by improving inflammatory markers, symptoms, and quality of life.

Eligibility criteria:
inclusion criteria: * adult patients with an established diagnosis of ibs-d as determined by rome iii or iv criteria * have ibs of at least moderate severity * must be on a stable dose regimen for at least 1 month prior to enrollment * willing to follow the leap program for 3 months * able to give informed consent * willing to complete the study exclusion criteria: * individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, cancer patients under treatment, and kidney failure * bmi of 40 or higher * pregnancy or planned pregnancy or lactation * any serious illness that will interfere with the study procedures or results * enrollment in active clinical trial/ experimental therapy within the last 30 days * currently on another dietary treatment approach
effects of herbst appliance therapy to improve airway dimension

Conditions: Angle Class II

Summary: herbst appliance is one of the most popular fixed functional appliances to treat orthodontic patients with small lower jaws. since small lower jaws are reported to be one of the main reasons to induce sleep disordered breathing(sdb) of children, herbst appliance can be used to treat sdb children. previously no study compared the effects of herbst appliance therapy with removable functional appliance on airway dimension, so it still remains unclear which kinds of functional appliance is more suitable for improving airway dimension. this study will assess the effect of herbst appliance on airway dimension and compare the effects with those of twin block appliance (a popular 24 hours used removable functional appliance, and also commonly used to treat adult sleep apnea).

sleep disordered breathing (sdb) is an important paediatric problem. it is estimated that 3.2% to 12.1% of children have habitual snoring and 0.7% to 10.3% have obstructive sleep apnea syndrome (osas). children osas is associated with a series of daytime and nighttime signs and symptoms. nighttime symptoms include heavy snoring, restless sleep, heavy seating and enuresis, etc. daytime symptoms include excessive daytime sleepiness and abnormal behavior such as aggressiveness and hyperactivity, etc. untreated osas was reported to result in serious morbidity, such as failure to thrive, poor learning, attention deficit and hyperactivity disorder, etc. there is an increasing concern related to sleep disordered breathing(sdb) of children by orthodontists. since not only the tonsilar and adenoid hypertrophy is the main cause of paediatric osa, but also craniofacial anomalies such as retrognathic mandible, narrow maxillary palatal arch and increased lower facial height can also contribute to it, orthopedic treatment such as rapid maxillary expansion (rme) and mandibular advancement device (mad) may potentially permanently cure the children osa. rme which is used to widen maxilla, thus increasing the nasal cavity and improving the nasal flow, has been thoroughly researched. however, only a few previous studies focused on the treatment effect of mad for treating osa children. these studies showed sorts of mad such as jaw-positioning appliance, mono-block, and herbst appliance were effective to osa children, but it remains unclear how to choose a functional appliance, and if there is any treatment difference between removable functional appliance and fixed functional appliance for improving airway dimension.

Eligibility criteria:
inclusion criteria: 1. class ii malocclusion exclusion criteria: 1. cleft lip and palate 2. craniofacial syndrome
a clinical trial to evaluate the efficacy and safety of defocusing lenses in delaying myopia progression

Conditions: Myopia

Summary: the objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. a total of 156 subjects meeting the requirements of the study protocol were included. during the study, subjects were required to wear the test product (defocus lens a or defocus lens b) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. during the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.


Eligibility criteria:
inclusion criteria: participants must meet all criteria to be enrolled in the study at the screening visit: 1. age 8\~13 years old (including boundary values), gender is not limited; 2. the spherical degree of subjective optometry in both eyes with cycloplegic muscle paralysis was between -1.00d and -6.00d (including the boundary value) (based on the mean value of subjective optometry), and the equivalent spherical difference of both eyes was less than 1.50d; 3. optimal corrected visual acuity ≥1.0 in left and right eye after ciliary muscle paralysis; 4. in both eyes with cycloplegia, the degree of the column lens was ≤1.50 days; 5. voluntarily participate in the clinical study, sign the informed consent, and obtain the written consent of the guardian; exclusion criteria: subjects who met any of the following criteria at the time of the screening visit were excluded from the study: 1. have a history of eye trauma or intraocular surgery; 2. abnormal results of slit-lamp examination (see annex 1 for details); 3. fundus examination results ≥ grade 2 (see annex 1 for details); 4. intraocular pressure \ 21mmhg or intraocular pressure difference ≥5mmhg; 5. patients with other eye diseases, such as uveitis and other inflammation, glaucoma, cataract, fundus disease, eye tumors, eye trauma, dominant strabismus, and any eye lesions affecting visual function; 6. associated diseases that may affect the eye (such as acute and chronic sinusitis, diabetes, down syndrome, rheumatoid arthritis, etc.); 7. suffering from a mental disorder or other disease that the researcher deems unsuitable for wearing frame glasses; 8. use specially designed myopia control lenses such as hard contact lenses (including care products), multifocal contact lenses, progressive multifocal lenses, and atropine drugs within 1 month before screening or during the planned study period; 9. participating in other clinical trials within 3 months prior to screening; 10. those who cannot perform regular eye examination; 11. other investigators consider it inappropriate to participate in this clinical study.
the usability and injection time of the physiolis syringe and autoinjector in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this was an open-label, phase 2 study designed to obtain user experience data (phase a) and injection time data (phase b) in experienced adalimumab patients injected with the physiolis pre-filled syringe and autoinjector used to administer adalimumab.

this was a phase 2, open-label study consisting of 2 study phases with a total of 3 study visits, each visit occurring 2 weeks apart from each other. phase a (user experience) was a randomized, 2-period, cross-over phase in which single subcutaneous (sc) dose injections were administered using either the physiolis autoinjector and current autoinjector or the physiolis syringe and current syringe in a 1:1 ratio. phase b (injection time) was a randomized, single-visit, parallel-arm phase, with injection into a test tube, and one sc injection given to participants using the physiolis autoinjector or current autoinjector administered at 2 different temperature ranges (2° to 8°c \[storage temperature\] and 20° to 27°c \[room temperature\]). if a participant only completed visit 1 and visit 2, then the participant was to be replaced for visit 3. if the participant only completed visit 1, the participant was to be replaced for all study visits.

Eligibility criteria:
inclusion criteria: * subject was judged to be in good health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and a 12-lead electrocardiogram performed during screening. * subject had a negative purified protein derivative (ppd) test (or equivalent) and chest x-ray (posterior-anterior and lateral view) at screening. * subject has a diagnosis of moderate to severe rheumatoid arthritis and is treated with adalimumab in accordance with the fda-approved humira prescribing information. * subject must have self-administered adalimumab subcutaneous (sc) 40 mg injections every other week (eow) without interruption for at least 3 months prior to screening. * for the phase a portion of the study, the subject must be able and willing to self administer sc injections in the thigh or abdomen (administration by another person was not permissible). exclusion criteria: * subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the visit 1, with the exception of adalimumab. * infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the visit 1 or oral anti-infectives within 14 days prior to visit 1. * prior exposure to natalizumab (tysabri®) or efalizumab (raptiva®). * known hypersensitivity to adalimumab or its excipients. * regular use of any sc medications, with the exception of adalimumab.

Keywords: rheumatoid arthritis
comparative analysis of different tests to evaluate prognosis of patients on liver transplant waiting list

Conditions: Cirrhosis; Liver Failure; Portal Hypertension

Summary: it is a cohort to evaluate the power of different diagnostic tests in predicting the prognosis of patients with severe liver disease. patients with decompensated liver cirrhosis on the waiting list for liver transplantation will be evaluated with comparison of different diagnostic tests according to the meld score (model for end-stage liver disease), meld-na (model for end-stage liver disease and sodium), indocyanine green clearance test, hepatic venous pressure gradient and transient elastography. all patients will be submitted to all the tests and prospectively followed for 6 months, to establish mortality and complications related to liver disease in order to define the value of each method to predict outcomes.


Eligibility criteria:
inclusion criteria: * the study includes patients (80 patients) * were male and female * aged between 18 and 69 years with chronic liver disease * with meld inclusion greater than or equal to 14 to 30 exclusion criteria: * they have been transplanted * have a diagnosis of primary malignant liver (hcc) signed by imaging tests performed * meld scores greater than 30.

Keywords: portal hypertension elastography hepatic venous pressure gradient measurement